Global Harmonization Task Force
Encyclopedia
The Global Harmonization Task Force (GHTF) is “a voluntary group of representatives from national medical device
regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device
industry
” whose goal is the standardization of medical device regulation across the world. The representatives from its five founding members (the European Union
, the United States
, Canada
, Japan
and Australia
) are divided into three geographical areas: Europe
, Asia-Pacific
and North America
, each of which actively regulates medical devices using their own unique regulatory framework. Founded in 1992, the GHTF was created in “an effort to respond to the growing need for international harmonization in the regulation of medical device
s."
The GHTF also serves as an information exchange forum through which countries with medical device regulatory systems under development can benefit from the experience of those with existing systems and/or pattern their practices upon those of GHTF Founding Members.”
Stated succinctly, the organization aims to standardize medical device regulations around the world by exchange of information.
The Steering Committee members consist of up to 8 members from each of the Founding Members’ regions. Of the 8 members, up to 4 may be from the regulatory sectors and up to 4 from the industry sectors. The Chain and Vice Chair members of the controlling region are not to be included in this number.
and industry technical experts.
Examples of documents put out by Study Group 1 include Principles of Medical Devices Classification, and Labeling for Medical Devices.
Examples of documents put out by Study Group 2 include http://www.ghtf.org/sg2/inventorysg2/SG2-N57-R8-Conten-of-Field-Safety-Notices-FINAL.pdfMedical Devices Post Market Surveillance
: Content of Field Safety Notices], Manufacturer's Trend Reporting of Adverse Events and National Competent Authority Report Exchange Criteria including reference to the use of the GMDN
.
Examples of documents put out by Study Group 3 include Implementation of Risk Management Principles and Activities Within a Quality Management System and Quality Management Systems - Process Validation Guidance.
Examples of documents put out by Study Group 4 include Training Requirements for Auditors and Guidelines for Regulatory Auditing of Quality Management.
Study Group 5 has yet to produce any final documents, but areas of proposed topics include Clinical Evaluation and Clinical Evidence.
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
industry
Industry
Industry refers to the production of an economic good or service within an economy.-Industrial sectors:There are four key industrial economic sectors: the primary sector, largely raw material extraction industries such as mining and farming; the secondary sector, involving refining, construction,...
” whose goal is the standardization of medical device regulation across the world. The representatives from its five founding members (the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
, the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, Canada
Canada
Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...
, Japan
Japan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
and Australia
Australia
Australia , officially the Commonwealth of Australia, is a country in the Southern Hemisphere comprising the mainland of the Australian continent, the island of Tasmania, and numerous smaller islands in the Indian and Pacific Oceans. It is the world's sixth-largest country by total area...
) are divided into three geographical areas: Europe
Europe
Europe is, by convention, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally 'divided' from Asia to its east by the watershed divides of the Ural and Caucasus Mountains, the Ural River, the Caspian and Black Seas, and the waterways connecting...
, Asia-Pacific
Asia-Pacific
Asia-Pacific or Asia Pacific is the part of the world in or near the Western Pacific Ocean...
and North America
North America
North America is a continent wholly within the Northern Hemisphere and almost wholly within the Western Hemisphere. It is also considered a northern subcontinent of the Americas...
, each of which actively regulates medical devices using their own unique regulatory framework. Founded in 1992, the GHTF was created in “an effort to respond to the growing need for international harmonization in the regulation of medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
s."
Mission statement
As quoted from the GHTF site, “The purpose of the GHTF is to encourage the convergence in regulatory practices related to ensuring the safety, effectiveness/performance and quality of medical devices, promoting technological innovation and facilitating international trade, and the primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices. These documents, which are developed by four different GHTF Study Groups, can then be adopted/implemented by member national regulatory authorities.The GHTF also serves as an information exchange forum through which countries with medical device regulatory systems under development can benefit from the experience of those with existing systems and/or pattern their practices upon those of GHTF Founding Members.”
Stated succinctly, the organization aims to standardize medical device regulations around the world by exchange of information.
Founding members
The founding members consist of regulatory authorities or industry members from the EU, USA, Japan, Australia and Canada because of their well established and high standards in medical device regulations. Members also participate in the steering committee, which can recommend the inclusion of other participants in Study Groups to be a part of all GHTF activities.Participating members
Participating members consist of representatives from regulatory agencies or medical device trade associations not a part of the founding members. Participating members are to facilitate the adoption of as much of the GHTF’s policies in their region/agency as possible within legal parameters. Participating members can also take part in Study Groups as well as other expert working groups.Liaison bodies
Liaison bodies are public health organizations, international standard-setting bodies or other groups who can contribute to or benefit from participation in GHTF. Liaison Bodies are encouraged to promote GHTF guidelines to their members and incorporate them into their work. Liaison bodies are permitted to nominate observers for GHTF Study Groups and other expert working groups.Observers
Observers must be nominated by members and approved by the Study Group Chair. The level of participation that an Observer is granted is also decided by the Study Group Chair.Steering committee
The purpose of the Steering Committee is to provide policy and direction for the GHTF. It is responsible for the assignment and oversight of new work items, adopt and monitor GHTF guidance documents and the authorization and promotion of GHTF training events.The Steering Committee members consist of up to 8 members from each of the Founding Members’ regions. Of the 8 members, up to 4 may be from the regulatory sectors and up to 4 from the industry sectors. The Chain and Vice Chair members of the controlling region are not to be included in this number.
Study groups
There are five study groups in the GHTF, each with a different focus. The size of each Study Group is to be determined by the Study Group Chair. Recommended members include one participant from each region with founding member status as well as appropriate numbers from regulatory agenciesRegulatory Authority
A regulatory agency is a public authority or government agency responsible for exercising autonomous authority over some area of human activity in a regulatory or supervisory capacity...
and industry technical experts.
Study Group 1
Study Group 1 is concerned with the current medical device regulatory systems. From examining the current field, the group isolates the principles suitable for harmonization as well as those that pose a threat to harmonization. The Group also deals with the standardization of pre-market submissions and product labeling.Examples of documents put out by Study Group 1 include Principles of Medical Devices Classification, and Labeling for Medical Devices.
Study Group 2
Study Group 2 is concerned with medical device vigilance such as medical device reporting and post market surveillance. The Group is designed to harmonize the data collection and reporting systems of the industry.Examples of documents put out by Study Group 2 include http://www.ghtf.org/sg2/inventorysg2/SG2-N57-R8-Conten-of-Field-Safety-Notices-FINAL.pdfMedical Devices Post Market Surveillance
Postmarketing surveillance
Postmarketing surveillance is the practice of monitoring the safety of a pharmaceutical drug or device after it has been released on the market and is an important part of the science of pharmacovigilance...
: Content of Field Safety Notices], Manufacturer's Trend Reporting of Adverse Events and National Competent Authority Report Exchange Criteria including reference to the use of the GMDN
GMDN
GMDN or Global Medical Device Nomenclature is a system of internationally agreed generic descriptors used to identify all medical device products...
.
Study Group 3
Study Group 3 is concerned with examining and harmonizing current quality systems requirements.Examples of documents put out by Study Group 3 include Implementation of Risk Management Principles and Activities Within a Quality Management System and Quality Management Systems - Process Validation Guidance.
Study Group 4
Study Group 4 is concerned with examining current quality systems auditing practices and the harmonization of the auditing process.Examples of documents put out by Study Group 4 include Training Requirements for Auditors and Guidelines for Regulatory Auditing of Quality Management.
Study Group 5
Study Group 5 is concerned with the convergence of clinical practices. This includes the harmonization of clinical terms, reports and evaluations.Study Group 5 has yet to produce any final documents, but areas of proposed topics include Clinical Evaluation and Clinical Evidence.